This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: NexStent®
PMA Applicant: Endotex Interventional Systems, Inc.
Address: 10231 Bubb Road , Cupertino, CA 95014 USA
Approval Date: October 27, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050025a.pdf
What is it? This device has two systems: the stent and either of two delivery systems; Over the Wire (OTW), or Monorail® (MR) used with an embolic protection system. The stent is a metal mesh cut from a nitinol folded sheet on a delivery system. T he NexStent® Carotid Artery and Monorail System. It is also compatible with the FilterWire EZ Ô Embolic Protection System; a system used at the same time to prevent small particles of plaque from getting to the brain during the procedure.
How does it work? The NexStent® Carotid Stent and Monorail® Delivery System is inserted during angioplasty, a less invasive procedure in which the stent is threaded up to the neck artery (carotid) via a catheter inserted in the groin.
- The Filterwire EZ™ Embolic Protection System is inserted into the vessel in the groin and advanced up to the blood vessel in the neck where there is blockage.
- The Filterwire EZ™ Embolic Protection System is opened up to allow blood to flow through, but small enough to catch any particles that may break off from the blockage during the carotid artery stenting procedure.
- After the Filterwire EZ™ Embolic Protection System is deployed, the physician advances the nitinol NexStent metal stent to the blocked area.
- The metal (nitinol) stent (NexStent® Carotid Stent with or without Monorail® Delivery System) is then allowed to open over the blockage.
- The physician may then utilize a standard dilation balloon made of latex to expand the NexStent®
- The catheter is removed, and another catheter is put up into the neck vessel to close the Filterwire EZ™ and remove it, along with any pieces of debris that were trapped.
When is it used? The Endotex® Carotid Stent and Monorail® Delivery System is used in patients who:
- have had a stroke
- who have a very tight (80%) blockage in the vessels of the neck
- have a lesser blockage with symptoms of a blockage of the neck vessels
- have either medical problems or body abnormalities that would put them at a high risk if they had the surgical alternative (called carotid endarterectomy).
What will it accomplish? The Endotex® Carotid Stent System forms a scaffold over plaque that is blocking the carotid artery in order to prevent future strokes. When compared to complications reported in literature from patients undergoing surgery, the risk of death, stroke and heart attack at 30 days and or any stroke in the area of the blockage at one year were similar.
When should it not be used? The Endotex Carotid Artery Stent System should not be used in patients who:
- cannot take blood thinners
- have bleeding disorders
- are allergic to nitinol
- have blockages at the beginning of the neck artery
- have problems preventing the catheter from getting to the blockage
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050025